PharmaKinetics Laboratories Inc. said yesterday that it had agreed to plead guilty to a charge of trying to obstruct a Food and Drug Administration investigation of the generic drug industry.
Federal prosecutors had charged the Baltimore drug-testing company and its former chief scientific officer with trying to prevent FDA investigators from getting incriminating evidence.
The company said it would pay a $200,000 fine in five installments of $40,000, plus 6.5 percent interest. Payment on the fine is to start in June 1992 and will be spread over five years.
PharmaKinetics and the former scientific officer, Mark B. Perkal, had been named as targets of a U.S. attorney's investigation last year. The probe stemmed from PharmaKinetics' association with Bolar Pharmaceutical Co., a Long Island, N.Y., generic drug manufacturer.
The U.S. attorney for Maryland had accused the New York firm of intentionally sending the brand-name hypertension drug Dyazide to PharmaKinetics for testing, instead of a generic equivalent made by Bolar. A bio-equivalency firm, PharmaKinetics sends generic drugs to the FDA for approval after testing them.
Prosecutors accused Dr. Perkal of allowing Bolar to replace Dyazide capsules with the generic equivalent after FDA inspectors asked to see capsules awaiting testing at PharmaKinetics in 1989.
PharmaKinetics and Bolar severed ties in 1989, causing PharmaKinetics to lose a substantial portion of its revenue stream. It filed for Chapter 11 bankruptcy last November.
"With this matter now behind us, PharmaKinetics plans to proceed with the filing of its plan of reorganization to emerge from Chapter 11," V. Brewster Jones, PharmaKinetics' president and chief executive officer, said in a statement.
Bolar was recently convicted of perpetrating a generic drug-switching scam and fined $10 million in U.S. District Court in Baltimore. Bolar also agreed to give up the right to make more than 150 generic drugs.
The U.S. attorney's office probe has so far resulted in the conviction of five FDA employees, four generic drug companies, 10 company executives and an industry consultant.